Cleaning device and methods

ABSTRACT

A method for providing therapy to tissue at a treatment site is performed by ablating tissue at the treatment site with an ablation device. Next, a cleaning device is attached to an instrument. The cleaning device attached to the instrument is used to remove ablated tissue at the treatment site. The cleaning device may also be used to remove debris from the treatment site prior to ablation or other therapeutic or diagnostic procedure.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD OF THE INVENTION

Aspects of the invention relate to the removal of tissue betweentreatment procedures. In one application, embodiments of the presentinvention provide cleaning devices and methods useful in removing debrisfrom tissue treatments. In other applications, embodiments of theinvention provide cleaning devices and methods useful in preparing thetissue or area of a treatment site in advance of treatment by removingmucus, blood and alimentary tract by products such as bile and feces,for example.

BACKGROUND OF THE INVENTION

During ablation procedures to treat various disease states, previouslytreated tissue in the ablation field can impair subsequent ablation ofthe same area if the treated tissue remains adherent to the ablationzone. Effectiveness of subsequent ablation will be diminished if treatedtissue is still present. To improve the procedure and efficacy ofablation, devices and techniques are needed to remove previously treatedtissue prior to subsequent ablation.

SUMMARY OF THE INVENTION

In one aspect, embodiments of the invention provide a method forproviding therapy to tissue at a treatment site. In one aspect, themethod includes ablating tissue at the treatment site with an ablationdevice. Next, the method includes attaching a cleaning device to aninstrument. Thereafter, ablated tissue is removed at the treatment sitewith the cleaning device attached to the instrument. In one aspect, theinstrument is an endoscope or an ablation device. In one specificembodiment, the removal of the ablated tissue is achieved throughphysical contact between the cleaning device and ablated tissue. In onespecific embodiment, the step of removing ablated tissue is achievedthrough abrasion or rubbing of ablated tissue. In one specificembodiment, the step removing ablated tissue is achieved throughscraping ablated tissue. Alternatively, the step of removing ablatedtissue is achieved through a combination of scraping, abrasion orrubbing of ablated tissue.

In another alternative embodiment, the cleaning device is moved from astowed condition to a deployed condition before the removing ablatedtissue step. In one aspect, the cleaning device is expanded before theremoving ablated tissue step is performed. In another alternativemethod, a step of removing material at the treatment site with acleaning device supported by an instrument is performed prior to theablating tissue step. In still other aspects, the material removed usingan embodiment of the method includes saliva, blood, mucus, food, bile,ablated tissue, or other alimentary canal by-products. In still otheraspects, the step of expanding the cleaning device to contact thetreatment site is done before performing the removal of ablated tissuestep. In another aspect, the step of advancing the cleaning device froma position within the instrument is done before performing the removalof ablated tissue step. In one aspect, the step of removing materialfrom the cleaning device is performed by withdrawing the cleaning deviceinto the instrument after the removing ablated tissue step. In anotheraspect, the method includes inducing homeostasis at the treatment sitewith the cleaning device. In another aspect, a portion of the cleaningdevice is constricted and expanded before the removing ablated tissuestep is performed. In another aspect, a portion of the tissue removedduring the removing ablated tissue step is stored in the cleaningdevice. In one embodiment, the removed tissue is stored in the pores ofthe cleaning device. And another alternative embodiment, the removedtissue is stored in a recess of the cleaning device.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which.

FIG. 1 is a flowchart illustrating one method of the invention;

FIG. 2 illustrates the use of a cleaning device within the esophagus;

FIG. 3 illustrates the use of an ablation device within the esophagus;

FIG. 4 illustrates treatment sites created within the esophagus as aresult of ablation;

FIG. 5 illustrates a cleaning device positioned at a treatment site;

FIG. 6 illustrates the use of a cleaning device to remove treated tissuefrom a treatment site;

FIGS. 7A and 7B illustrate perspective and end views, respectively, ofan ablation device;

FIGS. 8A and 8B illustrate perspective and end views, respectively, ofan ablation device with a cleaning device;

FIGS. 9A, 9B and 9C illustrate perspective, end and cross section viewsof a cleaning device;

FIGS. 10A, 10B and 10C illustrate alternative cleaning deviceembodiments;

FIGS. 11A and 11B illustrate a technique to secure a cleaning device toan instrument;

FIG. 12 illustrates the use of an adhesive on the ends of a cleaningdevice to secure the cleaning device to an instrument;

FIG. 13A illustrates a cleaning device in the form of a sheet with anadhesive backing;

FIG. 13B illustrates the cleaning device of FIG. 13A being applied to aninstrument;

FIG. 14 is a perspective view of a cleaning device with a slot to allowattachment to an instrument;

FIG. 15 is a perspective view of a cleaning device positioned on thedistal end of an instrument;

FIG. 16 is a perspective view of a cleaning device positioned on thedistal end of an instrument;

FIG. 17 is a perspective view of a cleaning device positioned to on thedistal end of an instrument;

FIGS. 18A and 18B are perspective and end views, respectively, of acleaning device positioned on the distal end of an instrument;

FIGS. 19A and 19B are perspective and end views, respectively, of acleaning device positioned on the distal end of an instrument;

FIGS. 20A and 20B are perspective and end views, respectively, of acleaning device positioned on the distal end of an instrument;

FIGS. 21A and 21B are perspective and end views, respectively, of acleaning device positioned on the distal end of an instrument;

FIGS. 22A and 22B are perspective and end views, respectively, of acleaning device positioned on the distal end of an instrument;

FIG. 23 is a perspective view of a cleaning device positioned on thedistal end of an instrument;

FIG. 24 is a perspective view of a cleaning device positioned on thedistal end of an instrument;

FIG. 25 illustrates a cleaning device in a stowed configuration within asheath;

FIG. 26A illustrates a cleaning device within a cavity in an instrument;and

FIG. 26B illustrates the cleaning device of FIG. 26A in use to removetissue.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is a flowchart 100 illustrating one embodiment of method of theinvention. First, at step 105, ablate tissue at a treatment site. FIG. 3illustrates the placement of an ablation device 80 within the esophagus10 at a treatment site 60. The ablation device 80 may be any deviceconfigured to ablate targeted tissue using any suitable ablationtechnique. Ablation may be achieved through any known technique andusing any of the wide variety of energy forms including the non-limitingexamples of radiofrequency (RF), IR light, laser, cryogenic, steam,convective heat, microwave and ultrasound. FIG. 4 illustrates atreatment site 60 or sites created within the esophagus 10 as a resultof ablation the ablation procedure. After ablation, treated tissue 62 ispresent at the treatment site 60.

Returning to FIG. 1, next at step 110, attach a cleaning device to aninstrument. Numerous alternative cleaning device designs are describedbelow. Alternatively, the cleaning device may be attached to theinstrument before the ablation occurs and/or be present while ablationoccurs. The instrument may be a shaft of sufficient length to allow thecleaning device to reach a treatment site within the body. Theinstrument may also be an endoscope or other therapeutic or diagnosticinstrument. As used herein, a cleaning device is any device adapted forremoving tissue from the treatment site using abrasion, scraping,rubbing, alone or in any combination. A cleaning device may be attachedto an instrument permanently, formed as part of a unitary structure ormay be removable from the instrument. A cleaning device may be a singleuse or reusable, with or without sterilization.

FIG. 2 illustrates the placement and use of a cleaning device 370 withinthe esophagus 10 at a treatment site 60. First, the cleaning device 370is attached to the distal end of the instrument 50. The instrument 50 isadvanced through the mouth (an insertion tube 82 is shown in place inthe mouth), past the pharynx 32 and into the esophagus 10.

In some embodiments, while the cleaning device passes any narrowedareas, such as the pharynx or upper esophageal sphincter, the devicemoves to a smaller size configuration against the instrument. Afterpassing the constriction, the cleaning device expands back to its fullydeployed size. In this way, the device is in a deployed condition whenthe device is finally positioned at the treatment site. Thecharacteristic of moving between a stowed and deployed condition couldbe a function of the compressible material in the cleaning device as inthe embodiments of FIGS. 9A-14. Additionally or alternatively, thecharacteristic of moving between a stowed and deployed condition couldbe a function of: the use of malleable scrapers as in FIGS. 18A-24;through the use of a sheath as in FIG. 25; or the use of a stowagechamber or working channel as an FIG. 26A.

The instrument 50 is advanced along the esophagus 10 until the cleaningdevice 370 is positioned in the desired location within the treatmentsite 60. FIG. 5 illustrates a close-up view of cleaning device 370 inproximity to the treatment site 60. Visualization of the esophagus andthe treatment site are provided by the instrument 50. Returning to FIG.2, the cleaning device 370 is moved relative to the treatment site 60 bymoving the instrument handle 18 as indicated by the arrows 20. Relativemovement and contact between the cleaning device 370 and the treatmentsite 60 results in removal of treated tissue 62 from the treatment site60 using any of a number of mechanisms alone or in any combination.Relative movement between the cleaning device 370 and the treatment site60 may be produced by rotating, vibrating, oscillating, or othermovement of the cleaning device 370 or a cleaning surface of a cleaningdevice in relation to the treated tissue 62 at the treatment site 60.

Returning to FIG. 1, next at step 115, remove ablated tissue at thetreatment site with the cleaning device. FIG. 6 illustrates the use of acleaning device 370 to remove treated tissue 62 from a treatment site60. The initial use of the cleaning device 370 produced the cleaned site64 where the ablated tissue 62 was removed. Ablated tissue 62 remains atthe treatment site 60. The cleaning device 370 and cleaning processcontinues until the ablated tissue 62 is removed or until the treatmentsite 60 is adequately prepared for a follow on ablation step, ifdesired. Once cleaning is completed or sufficiently complete such thatablation may resume, the treatment site 60 returns to the conditionillustrated in FIG. 3 where the treatment site 60 is ready for ablationand the ablation device 80 is in position.

Tissue removal may be accomplished through physical contact between acleaning surface or portion of the cleaning device and the tissue at thetreatment site. The cleaning device may be used in conjunction withflushing of the treatment site with liquids or air provided by theinstrument. The cleaning device may be manipulated to remove tissuethrough any of a number of different mechanisms. Embodiments of thecleaning devices of the present invention may remove tissue from atreatment site through abrasion, scraping and/or rubbing. As will beappreciated in the description that follows, one or more cleaningsurfaces of a cleaning device may be configured for rubbing, abrasionand/or scraping tissue.

Returning to FIG. 1, next at step 120, determine whether an additionaltreatment is needed at the treatment site. Based on the individual needsof the patient, multiple ablation steps may be performed in order toaccomplish the desired amount of tissue removal. Alternatively, it maybe desirable for multiple ablations between cleaning steps. Ifadditional treatment is needed, return to step 105 and ablate tissue ata treatment site. If no additional treatment is needed, the method ends.Steps 105, 110 and 115 may, if desired, be repeated numerous times toprovide a method of treatment where by ablated tissue from a previousablation therapy is removed from a treatment site before a subsequentablation therapy is provided at the treatment site. It is believed thatthe intermediate step of removing tissue from a previous ablation stepincreases the efficiency and efficacy of subsequent ablation steps. Alsothe uniformity of the tissue (no debris) enables a more controlled andsafer ablation.

FIGS. 7A and 7B illustrate perspective and end views, respectively, ofan ablation device 150 positioned on the distal end 52 of an instrument50. The ablation device 150 includes suitable electrical connectionsincluding conductive wires 133 to connect the ablation structure 130 toa power source (not shown) as is conventional in the RF ablation arts.The conductive wires 133 can be wrapped or drawn over a distal end ofthe longitudinal support 114 and pass beneath the support 114. Such anarrangement advantageously facilitates rotational movement of thelongitudinal support 114 by preventing binding or restriction ofrotational movement. Additionally or alternatively, the ablation device150 can further include one or more electrode trace 131. The one or moreelectrode trace 131 can be constructed and arranged to conform to atleast a portion of the longitudinal support 114. The one or more trace131 can be in electrical communication with an electrode 132 andconductive wire 133.

FIG. 7A illustrates the ablation device 150 in position at a treatmentsite 60 within the esophagus 10 prepared for use in methods for ablatingtissue. The ablation structure 132 is rotationally deflectable towardtissue at the target site 60 surface and the ablation structure 132 isactivatable to ablate tissue at the target site 60. The ablationstructure 132 is supported by an ablation device support structure. Theablation device support structure includes a base 112 with alongitudinal support 114 and a rotational support 116.

As best seen in FIG. 7B, the base 112 can be constructed and arranged inany of a number of ways to support the ablation device 150. In theillustrated embodiment, the base 112 is constructed and arranged toattach the ablation device 150 to an outside surface of the instrument50, here an endoscope. The base 112 may also be constructed and arrangedas a sheath and may also include a connecting element, a band or a strapto further secure the ablation device 150 to the instrument 50. In theillustrated embodiment, the base 112 includes a stop or lip 113 feature.The lip 113 can be constructed and arranged to function as a stopdesigned to aid in positioning the ablation device 150 in relation tothe instrument 50.

The longitudinal support 114 is also constructed and arranged to supportthe ablation structure 132 in cooperation with the base 112. The support114 can be made of any suitable material for withstanding the highenergy flux produced by the ablation structure 130. The longitudinalsupport 114 can be flexible, enabling rotation about two axes, therebyfurther permitting rotation of the longitudinal support 114 away fromthe longitudinal axis (not shown). In one embodiment the longitudinalsupport is made of an elastic material, for example, silicone. Othersuitable materials include, for example, urethanes or other polymers.

The rotational support 116 is adapted to permit at least a part of theablation structure 132 to rotate with respect to the longitudinalsupport's longitudinal axis.

As best seen in FIG. 7A, an actuator mechanism 134 is provided foractively governing the rotation of the longitudinal support 114.Generally the actuator mechanism 134 permits interconversion between arotationally constrained longitudinal support 114 and free rotation ofthe support 114. Additional details of various aspects of theconstruction and operation of ablation devices are described in UnitedStates Patent Application Publication US 2007/0118104 titled“Auto-Aligning Ablating Device and Method of Use” commonly assigned tothe assignee of the present application and incorporated herein byreference in its entirety.

FIGS. 8A and 8B illustrate perspective and end views, respectively, ofthe ablation device of FIGS. 7A and 7B with a cleaning device 290attached. In the illustrated embodiment, the cleaning device 290 is anembodiment of the device illustrated in FIG. 14. The cleaning device 290has a slot 293 sized to fit over the shaft of an instrument 50. Theinner surface of the cleaning device may include an adhesive to affixthe cleaning device to the instrument 50. The cleaning device slot 293may be configured to secure the cleaning device 290 to the instrument 50with a friction lock. As shown in FIGS. 8A and 8B, the slot 293 is sizedto fit onto and secure the cleaning device 290 to the shaft of theinstrument 50.

FIGS. 9A, 9B and 9C illustrate perspective, end and cross section viewsof a cleaning device 200. The cleaning device 200 includes a body 205having a distal end 210 and a proximal end 220 and an opening 225 on theproximal end sized to fit onto the distal end 52 of an instrument 50.The cleaning device distal end 210 may be closed so that the cleaningdevice 200 remains on the distal end of the instrument. Alternatively,the cleaning device distal end 210 may be opened so that the cleaningdevice 200 may be advanced proximal to the distal end 52 of theinstrument 50.

The cleaning devices described herein may be formed from any of a widevariety of abrasive materials including compressible andnon-compressible materials. For example, the cleaning device 200 may beformed from porous or foam materials including but not limited to:polyurethane esters, polyurethane ethers, micro-cellular urethanes,latex foams, natural sponge rubber, filter foams, conductive foams,melamine polyamide, polyesters, polyethers, polyethylene, chemicallycross-linked polyethylene, irradiation cross-linked polyethylene, EVA,neoprene, EPDM, nitrile vinyl, PVC, nylon, silicone, PTFE, EPTFE, openor closed cell forms, reticulated or non-reticulated foam structures,and plasma treated structures to increase material hydrophobicity.

Cleaning devices of the present invention may include one or morecleaning surfaces. The multiple cleaning surfaces provided by thecleaning device 200 are best seen in FIG. 9C. The distal end 210 mayinclude an edge or shaped surface 207. The angled surface proximal tothe distal end may provide an additional cleaning surface 209. Anothercleaning surface 211 may be provided along the longitudinal axis of thecleaning device body 205. The angled surface distal to the proximal endmay provide an additional cleaning surface 213.

FIGS. 10A, 10B and 10C illustrate alternative cleaning deviceembodiments. FIG. 10A illustrates a cleaning device 230 having a distalcleaning surface 233 including a distal edge 234. The angled cleaningsurface 235 proximal to the distal end is less defined than the similarcleaning surface 209 illustrated in the cleaning device 200 of FIG. 9C.Similarly, the angled surface 238 distal to the proximal end is alsoless defined than the similar cleaning surface 213 illustrated in thecleaning device 200 of FIG. 9C. The cleaning device 230 also includes alongitudinal cleaning surface 237.

FIG. 10B illustrates a cleaning device 240 having a short, blunt body242. Additionally, the cleaning device 240 has a distal cleaning surface243 formed by the blunt distal tip of the device. The cleaning device240 also includes a longitudinal cleaning surface 245.

FIG. 10C illustrates a cleaning device 250 similar to the cleaningdevice 200. The cleaning device to 50 includes a body 252 shapes to havea rounded tip cleaning surface 253, a distal end cleaning surface 255, alongitudinal cleaning surface 237 and a proximal cleaning surface 238.The cleaning device 250 differs from the cleaning device 200 and in thatnone of the cleaning surfaces on the cleaning device 250 contain anyedges common to the cleaning surfaces of cleaning device 200. Instead,the cleaning device 250 has an elongated shape similar to the cleaningdevice 200 without the edges. The cleaning surfaces of the cleaningdevice 250 are less distinct, not well defined and blend one into thenext as illustrated in FIG. 10C.

The cleaning device may be affixed to an instrument using any suitabletechnique. FIGS. 11A and 11B illustrate one technique to secure acleaning device to an instrument 50. The cleaning device 260 includes adistal cleaning surface 262, a longitudinal cleaning surface 237 and adistal opening 225 sized to fit the instrument 50. As best seen in FIG.11A, the cleaning device 260 is positioned onto the instrument distalend 52 with an elastic sleeve 291 positioned distal to the cleaningdevice proximal end. The cleaning device 260 is secured to theinstrument 50 by unrolling the elastic sleeve 291 as shown in FIG. 11B.

Alternatively, an adhesive may be used to affix a cleaning device to aninstrument. FIG. 12 illustrates a cleaning device 270 with a rolledproximal end 272 and rolled distal end 274. The exposed portion of therolled ends contacts the instrument outer surface when unrolled. Asuitable adhesive 275 is applied to the exposed surface as best seen inFIG. 12. When the rolled ends 272, 274 are unrolled, the adhesive 275secures the cleaning device 270 to the instrument 50.

The cleaning device need not limited to elongate, cylindrical, orrounded structures. A cleaning device may take any of a variety ofshapes. For example, a cleaning device they be a rectangular sheet. FIG.13A illustrates a cleaning device 280 in the form of a rectangular sheetwith an adhesive backing 275. The cleaning device 280 may be formed froman abrasive material or the sheet may be formed from a suitable basematerial with an abrasive surface or abrasive elements attached thereto.FIG. 13B illustrates the cleaning device 280 of FIG. 13A being appliedusing the adhesive backing 275 to a position proximal to the instrumentdistal end 52.

In other embodiments, the cleaning device may be shaped to conform to orattach to the outer surface of the instrument 50. Conforming to theouter surface of the instrument 50 includes conforming to the entireouter surface or only a portion of the outer surface. FIG. 14 is aperspective view of a cleaning device 290 with a c-shaped body 292having a longitudinal slot 293 to allow attachment to an instrument 50.The cleaning device 290 would partially conform to a suitably sizedcylindrical instrument, such as an endoscope for example. The slot 293allows the cleaning device 290 to snap onto the instrument 50 at anydesired position on the instrument (see FIGS. 8A and 8B).

A cleaning surface may also include all or a portion of the outersurface of a cleaning device. The outer surface includes the gross shapeof that surface, such as a cylindrical shape for example. The outersurface may also include features on that outer surface such as edges,frames or loops. While the descriptions above for FIGS. 9-14 may referto edges, sides, or portions of a particular shape of cleaning device,the cleaning surface may also include the cleaning device in itsentirety.

FIG. 15 is a perspective view of a cleaning device 310 positioned on theinstrument distal end 52. Optionally, a joint or attachment 78 securesthe cleaning device 310 to the instrument distal end 52. Alternatively,the cleaning device 310 and the instrument 50 are a single unitarydevice. The cleaning device 310 includes a distal end 311, a proximalend 309 and an opening 318. The cleaning device 310 includes a number ofcleaning surfaces. A portion of the cleaning surface 316 is positionedproximal to the distal end of the cleaning device 311. The cleaningsurfaces include, at least, the edge 312, the top surface 316 and outersurface 314. In one embodiment, the cleaning device 310 is a plasticendoscopic mucosal resection cap.

FIG. 16 is a perspective view of a cleaning device 320 positioned on thedistal end 52 of an instrument 50. The cleaning device 320 includes adistal end 321 and a proximal end 322. The cleaning device 320 includesa distal angled cleaning surface 323. The cleaning device 320 may beformed from a single spiral band or, alternatively, from a plurality ofsingle rings or bands joined together. In one aspect, FIG. 16illustrates an edge, here either distal end 321 or angled surface 323,that is supported by one or more of a frame, a ridge or a ring. Thespiral shaped bends 324 may also be cut from a tube using techniquessimilar to those used in the fabrication of stents.

The use of single or multiple bands produces a large number of cleaningsurfaces. One cleaning surface is the spiral ring outside surface 324.Another cleaning surface is an edge 326 of the spiral ring. The cleaningsurfaces on the cleaning device 320 may be smooth and as illustrated ortextured to improve cleaning efficiency.

Cleaning device 320 also illustrates one embodiment of the cleaningdevice having a cleaning surface such as the distal and 321 and anothercleaning surface that is non-continuous with a distal and 321 such asthe angled surface 323. Similarly, either the distal and 321 or theangled surface 323 are non-continuous cleaning surfaces with regard tothe bend cleaning surfaces 324. In another alternative, all or a portionof the spiral ring could be used to at least partially extend about theinstrument.

FIG. 17 is a perspective view of a cleaning device 330 positioned to onthe instrument distal end 52. Like the cleaning device of FIG. 16, thecleaning device 330 includes a longitudinally arranged ring 331 with anumber of cleaning surfaces. Cleaning surfaces of the ring 331 includeedges 334 and surfaces 332. In one aspect, the device 330 is attached tothe instrument 50 at both ends. When the distal end of the instrument 50is straight as illustrated, the ring 331 remains generally aligned alongthe longitudinal axis of the instrument 50. Because the device 330 isnot attached along its length, flexing or bending the instrument distalend 52 causes the ring 331 to flex causing the edges 334 to fan outwardto produce a multi-edge scraping structure. The device 330 alsoillustrates another example of an edge that is supported by one or moreof a frame, a ridge or a ring.

FIGS. 18A and 18B are perspective and end views, respectively, of acleaning device 340 positioned on the instrument distal end 52. Thedistal end cleaning device 340 includes two cone shaped scrapers namelyan outer cone 341 and an inner cone 342. The proximal end 343 of device340 is adapted to fit onto the instrument 50. The cone scrapers 341, 342are arranged about the instrument 50 with distal facing openings. Cone341 terminates in an edge 344. Cone 342 terminates in an edge 345. Inother embodiments, the cones 341 and 342 may terminate in multipleedges, textured edges, or combinations thereof. A recess 346 existsbetween the inner surface of cone 341 and outer surface of cone 342.Recess 346 allows for an area to retain debris produced as a result ofcleaning.

FIGS. 19A and 19B are perspective and end views, respectively, of acleaning device 350 positioned on the instrument distal end 52. Thedistal end cleaning device 350 includes three cone shaped scrapersnamely an outer cone 341, an inner cone 342 and an end cone 347. Theproximal end 343 of device 350 is adapted to fit onto the instrument 50.The cone scrapers 341, 342 and 347 are arranged about the instrument 50with distal facing openings. Cone 341 terminates in an edge 344. Cone342 terminates in an edge 345. Cone 347 terminates in an edge 348. Inother embodiments, the cones 341, 342 and 347 may terminate in multipleedges, textured edges, or combinations thereof. A recess 346 existsbetween the inner surface of cone 341 and outer surface of cone 342.Recess 346 allows for an area to retain debris produced as a result ofcleaning. Similarly, a recess 349 exists between the end cone 347 andthe inner cone 342.

FIGS. 18A, 18B, 19A, and 19B illustrate scrapers with a truncatedconical shape and a circular distal opening. Other shapes andconfigurations are possible. The distal openings may have an elliptical,oblong, or other non-circular shapes. In the illustrated embodiments,the cones are concentrically arranged relative to one another or to theinstrument 50. Other arrangements are possible. For example, the conesmay be arranged eccentrically about the instrument 50.

Moreover, while the previous embodiments illustrate cleaning surfacesthat are cones arranged about an instrument, other cleaning surfaceconfigurations are possible. For example, a single flap may be used.FIGS. 20A and 20B are perspective and end views, respectively, of acleaning device 360 positioned on the instrument distal end 52. Thecleaning device 360 includes a body 361 and a proximal end 363configured to engage with or remain on the instrument 50. A single flap362 extends from the body 361. The flap 362 terminates in a distal edge344. The flap distal edge 344 extends beyond the instrument distal end52. The flap 344 also includes a longitudinal edge 366 and a proximaledge 367. As illustrated, the distal edge 344, longitudinal 366 andproximal edges 367 are smooth. In other embodiments, the flap edges mayterminate in multiple edges, textured edges, or combinations thereof. Asbest seen in FIG. 20B, the flap 362 is arranged about the top portion ofthe instrument 50.

FIGS. 21A and 21B are perspective and end views, respectively, ofanother cleaning device positioned on the distal end of an instrumenthaving a single flap cleaning surface. The cleaning device 370 includesa body 371 with a proximal and 373 configured to engage with or remainon the instrument 50. A single flap 372 extends from the body 371 beyondthe instrument distal end 52. The flap 372 terminates in a distal edge344. The flap distal edge 344 extends beyond the instrument distal end52. The flap 372 also includes edge 366 and a tapered longitudinal edge377. As illustrated, the distal edge 344, tapered longitudinal edge 377and edge 366 are smooth. In other embodiments, each edge may includemultiple edges, be textured, be subjected to surface treatment, orcombinations thereof. As best seen in FIG. 21B, the flap 372 is arrangedabout the top portion of the instrument 50.

FIGS. 22A and 22B are perspective and end views, respectively, of amultiple flap cleaning device 380 positioned on the distal end of aninstrument. The cleaning device 380 includes a body 381 and a proximalend 383 configured to engage with or remain on the instrument 50. Threeflaps to 62, 382, and 384 extend distally from the body 381. The flap362, described above in FIG. 21B, terminates in a distal edge 344. Theflap 362 distal edge 344 extends beyond the instrument distal end 52.The flap 362 also includes a tapered longitudinal edge and a proximaledge as described above. The flap 382 terminates in a distal edge 344.The flap 382 distal edge 344 extends beyond and above the instrumentdistal end 52. The flap 382 also includes a tapered longitudinal edgeand a proximal edge. The flap 384 terminates in a distal edge 344. Theflap 384 distal edge 344 extends beyond and above the instrument distalend 52. The flap 384 also includes a tapered longitudinal edge and aproximal edge. The illustrated edges 344 are smooth. In otherembodiments, the flap edges 344 may terminate in multiple edges similarto windshield wiper blades, be textured or roughened, or combinationsthereof. As best seen in FIG. 22B, the flaps 362, 382 and 384 arearranged about the instrument distal end 52.

While illustrated as having a proximal end larger than the diameter ofthe instrument 50, in other embodiments of the cleaning devices in FIGS.20A-22B, the proximal end of the device is the same diameter so as toform a friction fit on the instrument 50 as illustrated in FIGS. 18A and19A.

FIG. 23 is a perspective view of a cleaning device 390 positioned on theinstrument distal end 52. The cleaning device 390 includes a pluralityof cleaning surfaces including surfaces 392 and edges 394. Recesses 396are formed where an edge 394 extends over a surface 392. The cleaningdevice 390 may be formed from organic or non-organic polymers wherebythe stiffness of the edges controlled by both material selection anddimension, is adequate to achieve scrapping. While illustrated assmooth, the surfaces 392 and edges 394 of the cleaning device 390 may betextured, roughened, or include surface features to increase thecleaning efficiency.

FIG. 24 is a perspective view of a cleaning device 400 positioned on thedistal end of an instrument 50. The cleaning device 400 includes a body402 on the distal end of an instrument. A flap 360, described above inFIG. 20A, is attached to the body 402 and extends beyond the instrumentdistal end 52. A ring 404 is attached to the body 402 proximal to theflap 360. The ring 404 includes cleaning surfaces in the form of surface405 and edges 406. The body 402 may be solid, semisolid, or a balloon orother inflatable structure. While illustrated as smooth, the surfacesand edges of the cleaning device 400 may be textured, roughened, orinclude surface features to increase the cleaning efficiency.

The device is illustrated in FIGS. 18-24, in addition to otherembodiments, illustrate cleaning devices where the cleaning device has aproximal end and a distal end and the proximal end has a circumferencethat nearly matches the circumference of the instrument and the distalend has a circumference larger than the instrument. Additionally, thevarious scrapers, edges and cleaning surfaces illustrated in the variousembodiments provide numerous examples of cleaning surfaces that arenon-continuous with other cleaning surfaces on the same cleaning device.

In an embodiment where the body is inflatable, the ring 404 and theportion of the flap 360 extending around the body 402 are expandablealong with the inflatable body. The use of an inflatable cleaning devicebody 402 allows the cleaning device 400 to advance to the treatment sitein a reduced diameter size (i.e., deflated). Once positioned at thetreatment site, the body 402 is inflated in order to place the cleaningsurfaces of the device 400 into contact with tissue at the treatmentsite.

In addition to using inflatable cleaning devices, other techniques arepossible to reduce the diameter of the cleaning device for advancementto a treatment site. For example, FIG. 25 illustrates a cleaning device350 (described above in FIG. 19A) in a stowed configuration within asheath 399. The sheath 399 is positioned around at least a portion ofthe cleaning device. Inside of the sheath 399, the flaps 342 are heldagainst the outer surface of the instrument 50 thereby reducing theoverall diameter of the cleaning device. As such, cleaning device 350illustrates an example of a cleaning device movable between a stowedcondition adjacent the instrument and a deployed condition for engagingtissue on the lumen. Additionally, the cleaning device 350, along withother embodiments described herein, illustrate a cleaning devicediameter in a stowed condition that is less than the diameter of thecleaning device in the deployed condition. In this way, a cleaningdevice may remain in a stowed condition during movement to a treatmentsite. Once positioned at the treatment site, the sheath 399 is withdrawnand the flaps 342 expand out into the open configuration illustrated inFIG. 19A. While described with reference to the cleaning device of FIG.19A, a sheath may be used to reduce the diameter or render a stowedconfiguration to any cleaning device embodiment described herein.

FIG. 26A illustrates a cleaning device 420 within a cavity 72 in aninstrument 50. The cleaning device 420 includes an expandable hoop orring mounted on a shaft 418. In the illustrated embodiment, the hoop isopen and when extended out of the cavity 72 will expand into contactwith the surrounding tissue. Alternatively, the hoop may be closed loopwith a fixed diameter selected for a particular treatment site. Thecavity 72 may be a dedicated port in the instrument 50 for storing thecleaning device 420. The cavity 72 may also be the working channel of anendoscope. While the cavity 72 is illustrated in use with a hoop stylecleaning device, is to be appreciated that either or both of the cavityand cleaning device may be modified to allow any cleaning devicedescribed herein to be deployed from a cavity or working channel of aninstrument.

FIG. 26B illustrates the cleaning device of FIG. 26A in use to removetissue. As illustrated, the cleaning device 420 has exited the cavity 72and expanded into contact with the tissue at a treatment site 60. FIG.26B also provides another example where in the diameter of the cleaningdevice in the stowed condition (FIG. 26A) is less than the diameter ofthe cleaning device in the deployed condition.

As used herein, and edge on a cleaning device may be a blunt edge. Ablunt edge is an edge on a cleaning device or a cleaning surface havinga shape, contour, texture or other form suited to the removal of debrisby rubbing, scraping or abrasion. As such, a portion of a cleaningdevice may comprise a blunt edge. Moreover, the blunt edge may besupported by one or more of a frame, a ridge or a ring as illustratedand described herein. Generally, during typical use, a blunt edge asdescribed herein will not lacerate tissue at a treatment site.

While the above description relates to the use of cleaning devices ofthe inventions during ablation treatments, the device and methods of theinvention are not so limited. Other alternative uses of the cleaningdevices are possible. For example, a cleaning device may be used toclean, wipe or otherwise remove debris such as, but not limited to,food, mucus, blood, or alimentary tract by-products such as bile, fecesand the like from the alimentary tract. Removal of this debris mayenhance visualization of the organ to aid in performing a diagnosis orevaluation. By removing debris as a result of using a cleaning device ormethod described herein, a physician or health care provider may bebetter able to determine the location of bleeding, evaluate or analyzetissue type, identify and/or localize a perforation or prepare an organfor a subsequent therapeutic or diagnostic treatment (e.g., biopsy,ablation, banding and the like).

Additionally, embodiments of the cleaning devices and methods describedherein may be used to produce hemostasis of alimentary tract bleeds.Utilizing the devices and methods described herein for tamponade, it isbelieved that temporary or permanent hemostasis could be achieved. Toassist in permanent hemostasis, the device may be coated with a materialto assist in thrombosis such as thrombin, fibrin, collagen or othersuitable coatings or pharmacological agents. Additionally oralternatively, the cleaning device may be formed from thrombin, fibrinor collagen or coated by partially or completely by these or similarmaterials. Additionally, the characteristics of the cleaning device suchas the roughness, porosity, absorption qualities such as a hydrophilicmaterial, material selection, and/or suitable conventional materialpretreatment may be used to adapt the device for particular applicationssuch as for cleaning, hemostats or for other applications.

While numerous embodiments of the present invention have been shown anddescribed herein, it is to be appreciated by those of skill in the artthat such embodiments are provided by way of example only. Numerousvariations, changes, and substitution will now occur to those skilled inthe art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

1. A method for providing therapy to tissue at a treatment site,comprising: ablating tissue at the treatment site with an ablationdevice; attaching a cleaning device to an instrument; and removingablated tissue at the treatment site with the cleaning device attachedto the instrument.
 2. The method for providing therapy according toclaim 1 wherein the instrument is an endoscope.
 3. The method forproviding therapy according to claim 1 wherein the instrument is anablation device.
 4. The method for providing therapy according to claim1 wherein the removal of the ablated tissue is achieved through physicalcontact between the cleaning device and ablated tissue.
 5. The methodfor providing therapy according to claim 1 wherein removing ablatedtissue is achieved through abrasion or rubbing of ablated tissue.
 6. Themethod for providing therapy according to claim 1 wherein removingablated tissue is achieved through scraping ablated tissue.
 7. Themethod for providing therapy according to claim 1 wherein removingablated tissue is achieved through a combination of scraping, abrasionor rubbing of ablated tissue.
 8. The method for providing therapyaccording to claim 1 further comprising: moving the cleaning device froma stowed condition to a deployed condition before the removing ablatedtissue step.
 9. The method for providing therapy according to claim 1further comprising: expanding the cleaning device before the removingablated tissue step.
 10. The method for providing therapy according toclaim 1 further comprising: Removing material at the treatment site witha cleaning device supported by an instrument prior to the ablatingtissue step.
 11. The method for providing therapy according to claim 10wherein the removed material comprises: blood, mucus, bile or alimentarycanal by-products.
 12. The method for providing therapy according toclaim 1 further comprising: expanding the cleaning device to contact thetreatment site before performing the removing ablated tissue step. 13.The method for providing therapy according to claim 1 furthercomprising: advancing the cleaning device from a position within theinstrument before performing the removing ablated tissue step.
 14. Themethod for providing therapy according to claim 1 further comprising:removing material from the cleaning device by withdrawing the cleaningdevice into the instrument after the removing ablated tissue step. 15.The method for providing therapy according to claim 1 furthercomprising: furthering homeostasis at the treatment site with thecleaning device.
 16. The method for providing therapy according to claim1 further comprising: constricting and expanding a portion of thecleaning device before the removing ablated tissue step.
 17. The methodfor providing therapy according to claim 1 further comprising: storing aportion of the tissue removed during the removing ablated tissue step inthe cleaning device.
 18. The method for providing therapy according toclaim 1 further comprising: storing a portion of the tissue removedduring the removing ablated tissue step in the pores of the cleaningdevice.